Intervention Based on Implicit Theories of Personality: Effects on Depression and Bullying (ITP)

October 1, 2018 updated by: Esther Calvete, University of Deusto

Prevention of Depression and Bullying in Adolescents by Means of an Intervention Based on Implicit Theories of Personality

This study evaluates the efficacy of an intervention based on the Implicit Theories of Personality (ITP) in Spanish adolescents. Half of participants received the ITP intervention, while the other half received an educational intervention.

Study Overview

Detailed Description

Depression and bullying are two problems arising in childhood and adolescence, which cause severe suffering. Although there are good intervention programs for children and adolescents at risk, the results for universal interventions have generally been poor. The current project will test the efficacy of an Intervention based on the Implicit Theories of Personality (ITP). This procedure has recently been developed at US by David S. Yeager and colleagues, with extraordinary results in the reduction of depression, stress, and aggression. The project includes the following aims: (1) the evaluation of the efficacy of the ITP on depressive symptoms (Study 1) and aggressive behavior (Study 2) in Spanish adolescents; (2) to test whether the intervention changes biological and cognitive variables; (3) to identify whether development and sex moderates the effects of the intervention; and (4) to test whether temperament moderates the effect of the intervention. The study involves the evaluation of the intervention in a sample of around 900 adolescents (12-18 years), randomly allocated to experimental and control condition. It is a field experiment conducted in high schools and involves multiple measures over time (self-reports and parent reports; as well as levels of cortisol, testosterone and DHEA in saliva in a subset -50%- of the participants). In summary, the project aims to respond to the challenge of health and wellness in the population through a randomized controlled trial with multiple sources of measure and from a biopsychosocial perspective. The ITP intervention has the potential to become a universal intervention to help reduce the rates of depression and bullying.

Study Type

Interventional

Enrollment (Actual)

882

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent by the adolescents and their parents.
  • To be fluent in Spanish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Incremental theory of personality
1 hour behavioral intervention (based on ITP) consisting on several tasks to be completed on paper individually.
The experimental intervention (originally developed by David S. Yeager and colleagues) teaches that individuals have the potential to change. It has three main parts. First, participants are asked to read scientific studies that provide evidence that behaviors are controlled by "thoughts and feelings in brains," and that pathways in the brain have the potential to be changed under the right circumstances. Second, participants read several testimonials purportedly written by upperclassmen to bring credibility to the ITP. Finally, participants are asked to write their own version of such a narrative. This self-persuasive writing exercise has been shown to facilitate the internalization of the intervention message, building on a long line of research on cognitive dissonance.
Other: Educational intervention
1 hour educational intervention (about the human brain) consisting on several tasks to be completed on paper individually.
The educational intervention involved scientific information about the human brain. It was designed to be parallel to the experimental intervention and, hence, it has also three main parts. First, participants are asked to read scientific information about the different areas of the brain and their specialties. Second, participants read several testimonials written by upperclassmen about their transition to high school and how their brains help them to adapt to the new space and all the physical differences of the building and the classes. Finally, participants are asked to write a letter to another student explaining the main things he or she has learned about the brain and thinks are important for adapting to the new physical environment in high school.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline scores of the Center for Epidemiologic Studies Depression scale (CES-D; Radloff, 1977) at 2 weeks, 6 months, and 12 months.
Time Frame: Baseline, 2 weeks, 6 months, and 12 months.
Self reported depressive symptoms during the last month (last week in the 1 week follow-up) measured by 20 items scored 0-3 (0 = rarely; 3 = most or almost all the time), yielding a total between 0 and 60.
Baseline, 2 weeks, 6 months, and 12 months.
Change from baseline scores of the Revised version of the Peer Experiences Questionnaire (RPEQ; Prinstein, Boergers, & Vernberg, 2001) at 2 weeks, 6 months, and 12 months.
Time Frame: Baseline, 2 weeks, 6 months, and 12 months.
Self reported levels of perpetration (9 items) of peer aggression in the school context during the last 6 months (last week in the 1 week follow-up). Each item is scored 1-5 (1 = never; 5 = several times per week), yielding a total between 18 and 90.
Baseline, 2 weeks, 6 months, and 12 months.
Change from baseline scores of the Cyber Bullying Questionnaire (CBQ; Calvete et al., 2012; Gámez-Guadix, Villa-George, & Calvete, 2014) at 2 weeks, 6 months, and 12 months.
Time Frame: Baseline, 2 weeks, 6 months, and 12 months.
Self reported levels of perpetration (9 items) of peer cyber aggression during the last 6 months (last week in the 1 week follow-up). Each item is scored 0-3 (0 = never; 3 = five or more times), yielding a total between 0 and 54.
Baseline, 2 weeks, 6 months, and 12 months.
Change from baseline levels of Cortisol, DHEA and testosterone (in saliva) at 2 weeks, 6 months, and 12 months.
Time Frame: Baseline, 2 weeks, 6 months, and 12 months.
A random subset of the participants (n = 546) have provided saliva samples to be assayed for neuroendocrine levels to measure cortisol, DHEA and testosterone. They were directed to transfer saliva from their mouths to a tube. The sample tubes were carefully labelled, and as soon as the session ended, saliva samples were sent to the assay laboratory (Medikosta IMQ Análisis Clínicos) and stored in a freezer at -80°C.
Baseline, 2 weeks, 6 months, and 12 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implicit Theories of Personality questionnaire (Yeager et al., 2014)
Time Frame: Baseline, 2 weeks, 6 months, and 12 months.
Self reported measure that assesses adolescents' implicit theories of personality during the last 6 months (last week in the 1 week follow-up) measured by 8 items scored 1-6 (1 = strongly disagree; 6 = strongly agree), yielding a total between 8 and 48.
Baseline, 2 weeks, 6 months, and 12 months.
Young Schema Questionnaire (YSQ-3; Young, 2006)
Time Frame: Baseline, 2 weeks, 6 months, and 12 months.
Self reported maladaptive cognitive schemas during the last 6 months (last week in the 1 week follow-up). The original version has 90 items, but for the purposes of this study, we have included 35 items of 7 subscales: defectiveness/shame (5 items), mistrust/abuse (5 items), entitlement superiority/grandiosity (5 items), failure to achieve (5 items), insufficient self control/self discipline (5 items), abandonment/instability (5 items), emotional deprivation (deprivación). Each item is scored 1-6 (1 = strongly disagree; 6 = strongly agree), yielding a total between 5 and 30 for each subscale.
Baseline, 2 weeks, 6 months, and 12 months.
Big Five Questionnaire for children (BFQ-C; Barbaranelli et al., 2003)
Time Frame: Baseline.
Self reported questionnaire that assesses five personality traits: openness to experience, conscientiousness, extraversion, agreeableness, and neuroticism. For the purpose of this study, we have used the 21 items from the extraversion and neuroticism subscales. Each item is scored 1-5 (1 =almost always untrue of you ; 5 = almost always true of you).
Baseline.
Revised version of the Early Adolescent Temperament Questionnaire (EATQ-R; Ellis and Rothbart, 2001).
Time Frame: Baseline.
Self reported questionnaire of that assesses temperament in adolescents. For this study, only the 10 items of the temperament domain of effortful control were used, which measure self-regulation aspects of temperament in adolescents with three subscales: inhibition control, attention and activation control. Each item is scored 1-5 (1 =almost always untrue of you ; 5 = almost always true of you), yielding a total between 1 and 50.
Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Esther Calvete, PhD, University of Deusto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data will be provided to the journals in which it is planned to publish the results of the study. In addition, the PI and research team will consider to make IPD available to other researchers after publishing the results of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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